RecruitingPhase 1NCT06539338

A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell Cancers That Came Back After Previous Treatment

A Two-Part Open Label Phase 1 Multicentre Study Evaluating the Safety of INT2104 Infusion in Female and Male Participants Aged 18 Years of Age and Older With Refractory/Relapsing B-Cell Malignancies


Sponsor

Kite, A Gilead Company

Enrollment

34 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this first-in-human study is to evaluate the safety and tolerability of INT2104 when administered to humans in a broad population of participants with refractory/relapsing B-cell malignancies. Preliminary efficacy information may also be obtained. INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor (CAR) specific for CD20 (CAR20). The lentiviral vector is designed to generate CAR T and CAR Natural Killer (NK) cells inside the body following intravenous (IV) administration. Study details include the following: * The study duration will be 5 years * The treatment duration will be a one-time intravenous (IV) infusion of INT2104


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment called INT2104 — a type of immune cell therapy — for people with B-cell lymphomas (cancers of certain white blood cells) that have come back after multiple previous treatments. The study is looking at whether INT2104 is safe and at what dose. **You may be eligible if...** - You are 18 or older with a type of B-cell lymphoma (such as diffuse large B-cell lymphoma or other B-NHL subtypes) that has relapsed or not responded to at least 2 prior treatments - Your tumor tests positive for a protein called CD20 - You have measurable disease visible on scans - You have not had more than one prior CAR-T cell therapy **You may NOT be eligible if...** - Your cancer does not have CD20 on the tumor cells - You have had more than one prior CAR-T or other genetically modified T-cell therapy - You are pregnant or unable to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICINT2104

INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)


Locations(3)

Westmead Hospital

Westmead, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Hospital MD Anderson

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06539338


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